"55111-197-05" National Drug Code (NDC)

Simvastatin 500 TABLET, FILM COATED in 1 BOTTLE (55111-197-05)
(Dr. Reddy's Laboratories Limited)

NDC Code55111-197-05
Package Description500 TABLET, FILM COATED in 1 BOTTLE (55111-197-05)
Product NDC55111-197
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSimvastatin
Non-Proprietary NameSimvastatin
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20070816
Marketing Category NameANDA
Application NumberANDA078425
ManufacturerDr. Reddy's Laboratories Limited
Substance NameSIMVASTATIN
Strength5
Strength Unitmg/1
Pharmacy ClassesHMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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